Associate Director, Engineering

Role: Technical Operations Associate Director, Validation Lead, supporting GMP manufacturing of antibody-drug conjugates (ADCs) in a new Wilmington, DE facility. Responsibilities: establish and lead the site validation organization, oversee validation strategies for drug substance and drug product, including master plans, process verification, cleaning, computer system validation, and lifecycle management; partner with engineering and quality teams to ensure compliance; participate in design, commissioning, qualification, and inspections; support tech transfer and regulatory filings. Requirements: Bachelor’s in engineering, science, or related field; 10+ years in validation, engineering, or technical operations within cGMP biologics or sterile manufacturing; experience supporting highly potent compounds, containment, isolator tech, ADC manufacturing preferred; proven leadership in validation, CQV, and regulatory readiness. High-Value: ADC manufacturing, biologics, sterile processes, containment systems, validation leadership, startup experience, regulatory compliance, GMP operations, high-potency drug handling, technical transfer, and inspection readiness. WorkSetup: On-site with 10% travel.